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Latest 'delegated regulation' of the Falsified Medicines Directive is promulgated
By means of publication in the Official Journal of the European Union, the EU has set the deadline for member states (with some exceptions) to have a authentication process, based on serial numbers on individual pharma packages, in place three years from now, or February 2019. That date is not far off from when pharma products in distribution in the US are to be verifiable by means of their unique serial number, as specified in the Drug Supply Chain Security Act (DSCSA) of 2013. (US manufacturers currently are scrambling to meet a November 2017 deadline to have the serialization systems in place on their packaging lines; verification in downstream supply chains follows later.)
The new regulation, officially EU 2016/161, supplement to Directive 2001/83/EC, the Falsified Medicines Directive (FMD), isn’t a surprise or breakthrough; its text was more or less set back in October, and there were several revisions to that Directive that were published in 2011 and later. And it is up to each member state to set up its own national system, and to enforce the program within its borders on manufacturers and dispensers of drugs—with the result that there will be some variations from one country to another in how it’s applied. However, the EU is trying to maintain a commonality with all of the Union, because “parallel trade” of products going from one country to another is explicitly allowed for. (Iceland, Norway and Lichtenstein, members of the European Economic Area, as well as Switzerland, will participate in the FMD.)
The other hallmark of the EU system is that it is a “book end” approach, with serialization at the front end with the manufacturer, and verification at the tail end, at the point of dispensing, and considerable discretion for what happens in between. This is in contrast to the US system that ultimately will track movement of individual pharma packages at each change of ownership. Under the FMD, intermediaries (such as wholesalers) are instructed to perform verifications on a risk basis, with certain drugs and certain transactions, but not as a matter of course. On the other hand, the directive requires the use of tamper-evident seals on packages—something that is lacking in US regs.
In addition, the directive contains several sets of details on how central repositories are to be set up: they can be either national or “supranational,” and all connecting to a European Hub. The repositories are to be “nonprofit legal entities” and are to be funded by manufacturers or brand owners. Repository-level data access is yet to be worked out in the US.
The European Medicines Verification Organisation (EMVO), set up last year by a consortium of most of the major European pharma trade associations, “welcomes” publication of the regulation; it has already set up the European Hub for international data exchange. “There is still a lot of work to do, and the implementation time is short,” said EMVO President Sonia Ruiz Moran in a statement. “But the EMVO is confident that with the clarity of the [delegated acts] now established and the solid pre-work done over the last few years, the European Pharma Supply Chain stakeholders are in a good position to establish the Europe-wide organisation and infrastructure of interoperable systems that will be essential to the provision of safe medicines to each and every European Citizen.”